Job Title: PDP | Talent Acquisition Specialist | Life Science Engineering | CQV & Project Controls
JOB SUMMARY
This position serves as the key technical leader interface with the External Partner for the Large Molecule Vaccines External Manufacturing (ExM) organization.
The individual will create, lead, and execute Change Controls within the organization. This role is crucial for supporting in-line commercial product technology transfers of vaccine drug substance to the External Partner and supporting our in-line products.
MAIN RESPONSIBILITIES
1. Provide technical support for vaccine drug substance and/or drug product processes to External Partners, including on-site support within the manufacturing facility.
2. Review manufacturing documents such as batch records, SOPs, job aids, and protocols.
3. Assist in process troubleshooting, manufacturing investigations, and review analytical results.
4. Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).
5. Collaborate across technical functions and External Partners to ensure successful support and manufacturing.
6. Author process change control documentation, technical communications, and manage process risks.
7. Provide technical oversight, management, and planning support for partnership models.
8. Guide External Partners in assessing process technologies, ensuring standards compliance, and verifying deliverables.
9. Lead risk assessment and mitigation planning for partners.
10. Support manufacturing process issues and provide guidance on process and capacity optimization.
11. Manage investigations and coordinate with impacted manufacturing sites.
12. Review process change requests, deviations, and Master Batch Record changes to minimize duplication.
13. Drive continuous process verification and performance monitoring.
14. Ensure External Partners are inspection-ready for new product introductions and transfers, collaborating with Operations, Quality, and Regulatory teams.
15. Understand regulatory requirements and develop efficient compliance strategies.
16. Collaborate with External Partners to achieve business goals and foster a shared culture.
EDUCATION/QUALIFICATIONS
1. Bachelor’s degree in Engineering or applicable Science; advanced degrees preferred.
2. 2-4 years of post-bachelor’s experience in pharmaceutical manufacturing, engineering, or technical support.
3. Strong problem-solving skills and leadership experience in resolving complex issues.
4. Excellent interpersonal, communication, and collaboration skills.
5. Experience leading cross-functional teams supporting manufacturing operations is preferred.
6. Innovative mindset with solid engineering fundamentals and troubleshooting skills.
Travel Requirements: >25% for partner assignments outside the primary location; flexibility and short-term travel may be required.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Engineering Services and Pharmaceutical Manufacturing
#J-18808-Ljbffr